Expanded Access trials sponsored by us, in partnership with manufacturers
A source of real world treatment outcomes data in your targeted population(s)
Experts in site feasibility and full cost recovery
A complete solution to the increasing expectations of wider engagement and access
Expanded Access programs are “Treatment-Use” clinical trials for patients who cannot take part in research trials for the particular therapeutic or diagnostic in serious unsolved disease areas. We take over the burden of sponsoring and managing these programs, because (a) we have specialist knowledge and experience, and (b) manufacturers must spend their resources on the controlled studies required for marketing approval.
Group-level Expanded Access clinical trials (not to be confused with single-patient “compassionate use”) allow meaningful numbers of patients and their physicians to explore a new investigational treatment with a well designed protocol and supply-chain to work in harmony with the continued clinical development of the particular treatment.
When integrated into the drug development cycle, Expanded Access trials bring many benefits to the drug company, including wider patient engagement, increased chances of discovering response-predictive biomarkers, and information that leads to more-highly targeted pivotal trials in historically difficult diseases.
WideTrial sponsors both large group and small to medium sized group EAPs. The allowable size and timing of the program depends on many factors, including the degree of medical need, the safety profile of the product, and the quality of existing clinical data. We have seen every kind of case in the 30 year history of U.S. Expanded Access. We’ll devise the right access strategy for your product.
WideTrial is a third-party sponsor of group-level Expanded Access programs (EAPs). The primary objective of any EAP is to provide pre-approval treatment options in situations of unmet medical need. For us, the secondary objective is to generate clinical data from a larger and more representative set of patients within the target indication. Many patients do not meet the enrollment criteria of traditional research trials, and bringing them into the drug development process can be a win for all parties.
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